Tonix Pharmaceuticals stock halted ahead of FDA approval news
Investing.com -- Trading was halted in Tonix Pharmaceuticals (NASDAQ:TNXP) stock Friday ahead of a major announcement that the U.S. Food and Drug Administration (FDA) has approved Tonmya for the treatment of fibromyalgia in adults.
The approval marks a significant milestone for the company as Tonmya becomes the first new FDA-approved therapy for fibromyalgia in over 15 years. Tonmya is a non-opioid, once-daily bedtime analgesic with a sublingual formulation designed for rapid absorption.
Fibromyalgia is a chronic pain condition affecting more than 10 million adults in the U.S., predominantly women. The FDA approval was based on two Phase 3 clinical trials involving nearly 1,000 patients, which demonstrated that Tonmya significantly reduced daily pain scores compared to placebo at 14 weeks.
"The FDA approval of Tonmya as a first-line treatment for fibromyalgia represents a landmark advancement for the millions of people in the U.S. suffering from the debilitating pain this condition causes," said Seth Lederman, CEO of Tonix Pharmaceuticals.
The company reported that Tonmya was generally well tolerated across three Phase 3 clinical trials with over 1,400 patients. Common adverse events included oral hypoesthesia, oral discomfort, abnormal product taste, and somnolence.
Tonix Pharmaceuticals expects commercial availability of Tonmya to begin in the fourth quarter of 2025. The company plans to host a webcast and conference call on Monday to discuss the approval further.
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